How to Determine If a Product is a Pharmaceutical Drug

Definition of Pharmaceutical Drugs (Iyakuhin)
Article 2: In this Act, "Pharmaceutical Drugs (Iyakuhin)" refer to the following:

1. Substances listed in the Japanese Pharmacopoeia.
2. Substances (excluding quasi-pharmaceutical drugs and cellular/tissue-based products) intended for use in the diagnosis, treatment, or prevention of diseases in humans or animals, which are not devices/equipment (meaning machinery/equipment, dental materials, medical supplies, sanitary supplies, as well as programs (meaning instructions for a computer, combined to produce a single result; the same shall apply hereinafter) and recording media on which they are recorded; the same shall apply hereinafter).
3. Substances (excluding quasi-pharmaceutical drugs, cosmetics, and cellular/tissue-based products) intended to affect the structure or function of the body of humans or animals, which are not devices/equipment.
4. In this Act, "Quasi-pharmaceutical Drugs (Iyaku-bugaihin)" refer to the following items that have a mild action on the human body:
5. Substances used for the purposes listed in (a) through (c) below (excluding those used for the purposes stipulated in item (ii) or (iii) of the preceding paragraph in addition to these purposes), which are not devices/equipment:
   a. Prevention of nausea or other discomfort, or of bad breath or body odor.
   b. Prevention of heat rash, sores, etc.
   c. Prevention of hair loss, hair growth, or hair removal.
6. Substances used for the purpose of controlling rats, flies, mosquitoes, fleas, or other similar organisms for the health of humans or animals (excluding those used for the purposes stipulated in item (ii) or (iii) of the preceding paragraph in addition to this purpose), which are not devices/equipment.
7. Among substances used for the purposes stipulated in item (ii) or (iii) of the preceding paragraph (excluding those listed in the preceding two items), those designated by the Minister of Health, Labour and Welfare.
   Reference Material:  (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics) (◆Act No. 145 of August 10, 1960)

Main Cases Classified as Pharmaceutical Drugs

• If any of the following apply, the product is generally determined to be a pharmaceutical drug.
  • Judgment based on ingredients If the product contains even one ingredient listed in the "List of Component Essences (Raw Materials) Used Exclusively as Pharmaceutical Drugs."
• Labeling/Advertising of Efficacy and Effects If "pharmaceutical-like efficacy and effects" such as the following are claimed.
  • Examples: "Strengthens physical strength," "Restores vitality," "Prevents aging"
  • Examples: "Improves high blood pressure," "Effective against cancer," "For the treatment of diabetes"
• Judgment based on form If the product has a "pharmaceutical-like form," such as an ampoule or sublingual tablet.
  • *Even for tablets or pills, they may be deemed pharmaceutical drugs if there is no clear indication on the container that it is a "food product."
• Specification of Dosage and Administration If a "pharmaceutical-like dosage and administration" is indicated, such as timing, interval, or amount.
  • Examples: "Take 2 tablets, 3 times a day, after each meal," "Wrap in oblaat (edible film) and take"

Main Cases Not Classified as Pharmaceutical Drugs

• Substances clearly recognized as food Vegetables, fruits, Foods for Specified Health Uses (TOKUHO), Foods with Function Claims, etc.
• Judgment based on ingredients If all included ingredients are on the "List of Component Essences (Raw Materials) Not Judged as Pharmaceutical Drugs as long as Pharmaceutical-like Efficacy and Effects are Not Claimed," AND no pharmaceutical-like efficacy or effects are claimed.

Reference Material:  (Regarding the Applicability of Pharmaceutical Drugs / Ibaraki Prefecture)



Confirmation Method
Please determine the pharmaceutical applicability by cross-referencing the definitions above, related notifications, and the intended use of the product for sale. If you are unsure, please organize the following information and consult with the prefectural pharmaceutical affairs division (Yakumuka).

• Product appearance (photos, etc.)
• Intended use, effects, etc., of the product
• What kind of effects its use has on the body
• The business operator's view and the points of uncertainty (in detail, using legal grounds, etc.)

​@K.Kamitani